针对下尿路症状和/或前列腺增生患者的局限性前列腺癌的在线自适应立体定向体部放射治疗（X-SMILE）。

Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE).

作者信息

Kroese Tiuri, Andratschke Nicolaus, Belka Claus, Corradini Stefanie, Marschner Sebastian, Liermann Jakob, Hörner-Rieber Juliane, Fink Christoph, Debus Jürgen, Silvia Fabiano, Tanadini-Lang Stephanie, Pouymayou Bertrand, Mencarelli Alessandro, Fesslmeier Debra, Schiess Antonia, Guckenberger Matthias, Mayinger Michael

机构信息

Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland.

Department of Radiation Oncology, LMU University Hospital, LMU Munich, Munich, Germany.

出版信息

Radiat Oncol. 2025 May 28;20(1):90. doi: 10.1186/s13014-025-02653-4.

DOI:10.1186/s13014-025-02653-4

PMID:40437508

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12117833/

Abstract

BACKGROUND

Stereotactic body radiotherapy (SBRT) for localized prostate cancer offers non-inferior oncological outcomes and toxicity profiles compared to conventionally or moderately hypofractioned radiotherapy regimens, with shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia.

METHODS

This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image (MRI)-guided online adaptive SBRT in patients with intermediate to high-risk localized prostate cancer (i.e. ≤ cT3a and Gleason score ≤ 9 and PSA ≤ 20 ng/ml) who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume > 60 mL). The primary outcome measure is urogenital toxicity grade ≥ 3 within 3 months after completion of SBRT (according to CTCAE V5.0) or treatment-related discontinuation. Our aim is to show an event rate of 3% below a clinically acceptable threshold which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30.

DISCUSSION

In cases of moderate to high IPSS or significant obstructive urodynamics, a pre-emptive transurethral resection of prostate (TURP) may be beneficial. Notably, 10-20% of prostate cancer patients receiving radiotherapy patients have a history of TURP. While TURP can improve obstructive symptoms, its impact on late toxicity, particularly in SBRT, requires further investigation. To mitigate the risk of urogenital toxicity, especially in the case of patients with lower urogenital tract symptoms and/or prostatic hyperplasia, emerging approaches like MR-guided adaptive SBRT and weekly SBRT have shown promise.

TRIAL REGISTRATION

ClinicalTrials.gov/NCT06834152.

PROTOCOL VERSION

Version 6.0.

摘要

背景

与传统或适度低分割放疗方案相比，立体定向体部放疗（SBRT）治疗局限性前列腺癌的肿瘤学结局和毒性特征不劣，且治疗时间更短。然而，SBRT可能并不适用于所有患者，尤其是那些有下尿路症状和/或前列腺增生的患者。

方法

本研究旨在评估每周计算机断层扫描（CT）或磁共振成像（MRI）引导下的在线自适应SBRT对中高危局限性前列腺癌（即≤cT3a且Gleason评分≤9且PSA≤20 ng/ml）患者的安全性和有效性，这些患者伴有下尿路症状（国际前列腺症状评分[IPSS]>12）和/或有前列腺增生（前列腺体积>60 mL）。主要结局指标是SBRT完成后3个月内泌尿生殖系统毒性≥3级（根据CTCAE V5.0）或与治疗相关的停药。我们的目标是显示事件发生率低于设定为20%的临床可接受阈值3%。在原假设下，这种α为0.05且检验效能为80%的设计导致预期病例数为30例。

讨论

在IPSS为中度至高度或存在明显梗阻性尿动力学的情况下，先行经尿道前列腺切除术（TURP）可能有益。值得注意的是，接受放疗的前列腺癌患者中有10-20%有TURP病史。虽然TURP可以改善梗阻性症状，但其对晚期毒性的影响，尤其是在SBRT中，需要进一步研究。为降低泌尿生殖系统毒性风险，尤其是对于有下尿路症状和/或前列腺增生的患者，像磁共振引导下的自适应SBRT和每周一次的SBRT等新方法已显示出前景。